MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a: implant date: n/a - lens was not implanted.Section d6b: explant date: n/a - lens was not implanted.Section e1: telephone number: (b)(6).Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of this review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation of the preloaded monofocal intraocular lens (iol), the surgeon observed the haptic to be damaged.The iol was discarded and the procedure was completed using a backup device.There was a 5 minute delay while the new device was being prepared.Through follow up, we learned that the plunger had passed over the iol, potentially causing the lens and haptic damage.This issue was found prior to patient contact.No patient injury was reported and no medical or surgical interventions were required.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 18-nov-2025.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection of the complaint device revealed that the handpiece was received with the plunger rod overriding the lens stuck in the cartridge.Viscoelastic residue was observed throughout the cartridge; stress marks and cartridge tip damage and bulging was observed.The cartridge was also observed to be damaged.No issues were identified with the lens module, device assembly, or plunger rod advancement.The plunger rod tip was observed to be bent.The lens could not be removed from the cartridge; however, a haptic was observed to be detached.The complaint issue of override was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.The complaint issues "haptic damaged" and "lens damaged" could not be confirmed.The other observed issues could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 23459076
• Report Number: 3012236936-2025-000266
• Device Sequence Number: 7969177
• Product Code: HQL
• UDI-Device Identifier: 05050474636088
• UDI-Public: (01)05050474636088(17)280713
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown